Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury (TBI)

Validation of Non- Invasive Regional Transcranial Oxygen Saturation (rSO2) by Comparison With Invasive Brain Tissue Oxygenation (PbtO 2) Measurement in Patients With Severe Traumatic Brain Injury

The purpose of this study is to investigate the relationship among regional transcranial oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion pressure (CPP) in patients with severe traumatic brain injury (TBI).

Study Overview

Detailed Description

Experience with rsO2 assessed by near infrared spectroscopy (NIRS) in patients with severe TBI is lacking. Reports about the usefulness of rSO2 are contradictory as regards its technical reliability and clinical value. Continuous time-domain analysis comparing rSO2, PbtO2 and CPP has never been carried out and the correlation among these variables remains largely unknown. A significant association between rSO2 and these clinically important variables would suggest that cerebral oximetry provides relevant data signifying that rSO2 might be a useful tool assessing cerebral oxygenation in selected patients with TBI.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seville, Spain, 41013
        • Hospital Universitario "Virgen del Rocío"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stable patients with severe traumatic brain injury (Glasgow Coma Scale < 9) monitored through intracranial pressure (ICP) and brain tissue partial pressure of oxygen (PbtO2) probe, inserted for indications other than inclusion in this study

Description

Inclusion Criteria:

  • Severe Traumatic Brain Injury (Glasgow Coma Scale < 9)
  • Having an intraparenchymal cerebral ICP/PbtO2 catheter previously inserted.
  • Expected length of ICU stay > 1 days

Exclusion Criteria:

  • Patient's relatives refusal to patient's inclusion in the study
  • Patients necessitating ongoing resuscitation
  • End-stage in which death is imminent
  • Deficient signal of rSO2 impeding its proper valuation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation between rSO2 and PbtO2
Time Frame: four months
four months

Secondary Outcome Measures

Outcome Measure
Time Frame
correlation between rSO2 and CPP
Time Frame: four months
four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Santiago R Leal-Noval, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
  • Study Chair: Aurelio Cayuela, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
  • Study Chair: Victoria Arellano, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
  • Study Chair: Yael Corcia, M.D., Hospital Universitario "Virgen del Rocío", Seville, Spain
  • Study Chair: Vicente Padilla, M.D., Hospital Universitario "Virgen del Rocío", Seville, Spain
  • Study Chair: Claudio Garcia-Alfaro, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
  • Study Chair: Antonio Marín, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
  • Study Director: Francisco Murillo, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
  • Study Chair: Rosario Amaya, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
  • Study Chair: Maria Dolores Rincón, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (Estimate)

June 23, 2008

Study Record Updates

Last Update Posted (Estimate)

April 6, 2009

Last Update Submitted That Met QC Criteria

April 3, 2009

Last Verified

April 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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